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Tea Tree Antiseptic (Integria Healthcare US Inc.)

Available Formats

Dosage Form Package Information Links
OIL 25 mL in 1 BOTTLE (51257-640-03) Label Information
OIL 10 mL in 1 BOTTLE (51257-640-01) Label Information
OIL 50 mL in 1 BOTTLE (51257-640-04) Label Information
OIL 15 mL in 1 BOTTLE (51257-640-02) Label Information

Complete Tea Tree Antiseptic Information

  • ACTIVE INGREDIENT

    Melaleuca Alternifolia (Tea Tree) Leaf Oil 100%


  • PURPOSE

    Antiseptic


  • INDICATIONS & USAGE

    treats minor cuts, minor burns, scrapes, abrasions, insect bites and stings.


  • WARNINGS

    For external use only

    • avoid contact with eyes, mouth, ears and other sensitive areas of the body
    • if contact occurs, rinse thoroughly with water

  • STOP USE

    Stop use and ask a doctor if condition worsens or does not improve within 7 days.


  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children

    • if swallowed, get medical help or contact a Poison Control Center right away.



  • DOSAGE & ADMINISTRATION

    • apply to the affected area
    • use sparingly by drop
    • children under 12 years of age: consult a doctor

  • STORAGE AND HANDLING

    store below 86 degrees F


  • PRINCIPAL DISPLAY PANEL

    Tea Tree Oil Antiseptic

    100% Pure

    Minimum 36% Terpinen-4-ol

    Tea Tree Oil 15 mL Carton

    Tea Tree Oil 15 mL Label




  • INACTIVE INGREDIENT

    None.


  • INGREDIENTS AND APPEARANCE
    TEA TREE ANTISEPTIC 
    melaleuca alternifolia oil
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:51257-640
    Route of Administration TOPICAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    TEA TREE OIL (UNII: VIF565UC2G) (TEA TREE OIL - UNII:VIF565UC2G) TEA TREE OIL 15 mL  in 15 mL
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:51257-640-01 10 mL in 1 BOTTLE
    2 NDC:51257-640-02 15 mL in 1 BOTTLE
    3 NDC:51257-640-03 25 mL in 1 BOTTLE
    4 NDC:51257-640-04 50 mL in 1 BOTTLE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    unapproved drug other 02/01/2011
    Labeler - Integria Healthcare US Inc. (962379454)
    Registrant - Integria Healthcare US Inc. (962379454)
    Establishment
    Name Address ID/FEI Business Operations
    Integria Healthcare (Ballina) 750660367 manufacture